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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K111164
Device Name EUNITY
Applicant
Client Outlook, Inc.
295 Hagey Blvd.
Waterloo,  CA N2L 6R5
Applicant Contact CHRISTIE EBY
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/26/2011
Decision Date 05/06/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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